title: Safety of once-daily insulin detemir in patients with type 2 diabetes treated with oral hypoglycemic agents in routine clinical practice.
abstract: BACKGROUND
  The aim of the present study was to identify demographic and treatment factors that were predictive of hypoglycemia in a large cohort of type 2 diabetic patients initiating insulin detemir.
  
  
  METHODS
  The present 24-week observational study of insulin initiation included 17 374 participants from 10 countries. Severe hypoglycemia was defined as an event requiring third party assistance; minor hypoglycemia was defined as a daytime or nocturnal glucose measurement <3.1 mmol/L.
  
  
  RESULTS
  Prior to initiating insulin therapy, 4.9% of the cohort reported hypoglycemia (pre-insulin hypoglycemia), with most (94.2%) reporting minor events and 9.6% reporting severe events. Compared with patients without pre-insulin hypoglycemia, those with pre-insulin hypoglycemia had a higher incidence of events of minor hypoglycemia (1.72 vs 4.46 events per patient-year [ppy], respectively), nocturnal hypoglycemia (0.25 vs 1.09 events ppy, respectively), and severe hypoglycemia (<0.01 vs 0.04 events ppy, respectively) at final visit. Age (P < 0.047), body mass index (P < 0.001), a prior history of microvascular disease (P < 0.001), pre-insulin hypoglycemia (P < 0.001), increased number of oral hypoglycemic agents (OHAs; P < 0.001), OHA intensification (P < 0.001), and the use of glinides (P = 0.004) were all found to be independently associated with the occurrence of hypoglycemia during the study.
  
  
  CONCLUSIONS
  Once-daily insulin detemir therapy was safe and effective, and rates of hypoglycemia were low. Concerns about hypoglycemia should not deter the initiation of basal insulin analogs.
authors.affiliation: Department of Medicine, University of Calgary, Calgary, Canada.
authors.forename: Stuart
authors.initials: S
authors.lastname: Ross
authors.forename: Grzegorz
authors.initials: G
authors.lastname: Dzida
authors.forename: Qiuhe
authors.initials: Q
authors.lastname: Ji
authors.forename: Marcel
authors.initials: M
authors.lastname: Kaiser
authors.forename: Robert
authors.initials: R
authors.lastname: Ligthelm
authors.forename: Luigi
authors.initials: L
authors.lastname: Meneghini
authors.forename: Avideh
authors.initials: A
authors.lastname: Nazeri
authors.forename: Domingo
authors.initials: D
authors.lastname: Orozco-Beltran
authors.forename: Changyu
authors.initials: C
authors.lastname: Pan
authors.forename: Anne Louise
authors.initials: AL
authors.lastname: Svendsen
mesh_terms: D000284:Administration, Oral; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000097:blood / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069057:Insulin Detemir; D049528:Insulin, Long-Acting / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011446:Prospective Studies; D012044:Regression Analysis; D018570:Risk Assessment; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D049528:Insulin, Long-Acting; D000069057:Insulin Detemir
keywords: ambulatory care; basal insulin; oral hypoglycemic agent; sulfonylurea; type 2 diabetes mellitus; 非卧床护理，基础胰岛素，口服降糖药，磺脲，2型糖尿病